Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Study participants were recruited at 43 sites from 9 countries: 28 in the US, 4 in India, 2 each in Brazil, Malawi, Peru and South Africa, and 1 each in Haiti, Thailand and Zimbabwe, between May 2005 to August 2007.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

HIV-infected, treatment-naive men and women, at least 18 years of age with CD4+ count <300 cells/mm^3.

> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed.

Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison) [ Time Frame: Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008) ]

Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) [ Time Frame: Week 48 using follow-up through study closure on May 31,2010 ]

Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) [ Time Frame: Week 96 using follow-up through study closure on May 31,2010 ]

Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study).

Additional Description

Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.